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Clinical Trials Support Specialist
2 months ago
ABOUT US:
At Alliance Clinical LLC, we are committed to enhancing medical advancements and therapeutic technologies through innovative research, dedicated patient care, and robust management practices. Our experienced management team and clinical staff focus on conducting efficient trials that expedite the availability of transformative medications; our research personnel possess extensive hands-on experience in executing Phase 1-4 clinical studies. Each research initiative is aimed at combating diseases and enhancing the quality of life for individuals.
WORK ENVIRONMENT: Onsite
POSITION SUMMARY: The Clinical Research Assistant, under the guidance and continuous oversight of the Principal Investigator, plays a crucial role in the daily operations of clinical research initiatives.
KEY RESPONSIBILITIES: The following duties are essential to this role, and additional responsibilities may be assigned:
- Adhere to all organizational policies, procedures, and conduct standards.
- Maintain strict confidentiality and compliance with regulatory standards.
- Engage effectively and courteously with study participants.
- Gather patient medical histories and current health conditions.
- Facilitate the acquisition of Informed Consent Forms.
- Manage study drug distribution and accountability.
- Collect and assess concomitant medications.
- Review medical records for compliance with study protocols.
- Conduct assessments for Adverse Events (A/E) and Serious Adverse Events (SAE).
- Perform EKGs, vital signs monitoring, and protocol-specific procedures.
- Collect, process, and ship biological samples including blood, urine, and tissue.
- Assist in the upkeep of regulatory files for the office site.
- Ensure the accuracy of collected data.
- Help document temperature records for investigational products stored on-site.
- Work directly with patients who have tested positive for COVID-19.
- Oversee all necessary study startup documentation, training, and timelines related to assigned study protocols.
- Meet all requirements and deadlines outlined in study protocols.
QUALIFICATIONS: To excel in this position, candidates must be able to fulfill each essential duty effectively. The qualifications listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in Biology or a related field is required.
- Proficiency in computer usage and data collection; expertise in Microsoft Office is required.
- Willingness to travel between site locations for clinical research activities is required.
- Prior research experience is preferred but not mandatory.
- Certification as a Medical Assistant is preferred.
- 1-2 years of Phlebotomy experience is required.
- Technical skills such as EKG are preferred based on protocol requirements.
- Familiarity with medical terminology is beneficial.
- Ability to operate with minimal supervision.
- Strong problem-solving skills and a quick learning ability are essential.
- Excellent verbal and written communication skills are necessary.
- Outstanding customer service skills with both internal and external stakeholders.
- A proven capacity to manage multiple tasks in a fast-paced environment.
BENEFITS:
We offer a comprehensive benefits package including:
- 401k Plan with employer matching
- Medical, Dental, and Vision coverage
- Paid Time Off (PTO) and paid holidays